Naloxone Hydrochloride

Product NDC: 0641-6260
11-digit product format: 006416260
Labeler code: 0641
Product ID: 0641-6260_531da15c-9a2c-4121-9aa5-85b079d3908b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nalxone Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA070299
Marketing category: ANDA
Marketing start: 2022-03-01
Substance: NALOXONE HYDROCHLORIDE
Active strength: .4 mg/mL
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070299-001	NALOXONE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP		1986-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A070299-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070299-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070299-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070299-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070299-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070299-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070299-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070299-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070299-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070299-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070299-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070299-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070299-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070299-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070299-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070299-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070299-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070299-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070299-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070299-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070299-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070299-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070299-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070299-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070299-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070299-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070299-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070299-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070299-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070299-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070299-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070299-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070299-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070299-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070299-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070299-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070299-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070299-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070299-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070299-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070299-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naloxone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALOXONE HYDROCHLORIDE	.4 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F850569PQR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1659929	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1bef59b9-7d51-4f19-a054-44b8eb6c6398	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c955d208-c333-9bd7-be34-d7e12986d44e	Product name	6	20250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304	Product name	1	20250204
caa6391e-3db3-c912-335f-61b5fc00aa12	Product name	9	20240110
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
65a3bc34-04ff-4cf1-aad9-c7d92a062f6d	Product name	1	20231003
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
e951cdf3-f269-4d97-a7d5-c1c3d7283a7d	Product name	3	20230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39	Product name	4	20230306
f327b80c-8fa2-404b-838a-df3eec141cf2	Product name	1	20221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119	Product name	1	20220511
b871fccd-1de6-4c7f-b9e5-045304641ee6	Product name	8	20220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9	Product name	1	20211026
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
4c23a34c-e8fc-424c-8fa0-ee064ba6eaef	Product name	1	20170706
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
0b8c7273-1da3-495f-909a-7cf1e96d2361	Product name	1	20161212
3df867ed-9d48-45cf-bded-1394beaea0b1	Product name	3	20161206
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6260-01	Naloxone Hydrochloride	1 mL in 1 VIAL	INJECTION	1		2
0641-6260-25	Naloxone Hydrochloride	25 in 1 CARTON	INJECTION	25		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6260	NALOXONE HYDROCHLORIDE (NALXONE HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]	2	Current NDC, Legacy NDC, 2 package rows	20240411_1bef59b9-7d51-4f19-a054-44b8eb6c6398.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naloxone Hydrochloride	NALXONE HYDROCHLORIDE	Civica, Inc.	21d20dff-6efe-481e-a5a0-9c80ded73ca9	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070299 application number: ANDA070299
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	3ba53405-5e72-c035-e063-6294a90ac0b1	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070299 application number: ANDA070299
Naloxone Hydrochloride	NALXONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1bef59b9-7d51-4f19-a054-44b8eb6c6398	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070299 application number: ANDA070299 ndc (product): 0641-6260
Naloxone Hydrochloride	NALXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	8959171f-eda6-158c-e053-2995a90a36b2	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070299 application number: ANDA070299
Naloxone Hydrochloride	NALXONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	8cc25cf1-008c-4808-baec-49f35a887fae	2020-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070299 application number: ANDA070299

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F850569PQR	NALOXONE HYDROCHLORIDE	357-08-4	NALOXONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1659929	naloxone HCl 0.4 MG in 1 ML Injection	PSN	1bef59b9-7d51-4f19-a054-44b8eb6c6398	2
1659929	1 ML naloxone hydrochloride 0.4 MG/ML Injection	SCD	1bef59b9-7d51-4f19-a054-44b8eb6c6398	2
1659929	naloxone HCl 0.4 MG per 1 ML Injection	SY	1bef59b9-7d51-4f19-a054-44b8eb6c6398	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6260-01	00641626001	1 mL in 1 VIAL	1 ml					Historical
0641-6260-25	00641626025	25 VIAL in 1 CARTON (0641-6260-25) / 1 mL in 1 VIAL (0641-6260-01)	25 vial	2022-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naloxone Hydrochloride Injection, USP	Hikma Pharmaceuticals USA Inc.	2024-04-10	HUMAN PRESCRIPTION DRUG LABEL	2